leva Renovia

Digital Therapeutic Device for Urinary Incontinence

The prescription leva Pelvic Health System (Renovia) is the first device to offer a digital therapeutic therapy for pelvic floor muscle training to improve symptoms of urinary incontinence and fecal incontinence. In study findings published in Obstetrics & Gynecology, leva achieved significantly greater urinary incontinence symptom improvement than a standard home pelvic floor muscle training program at 6 and 12 months. Read more.

Source: Contemporary OB/GYN.net, March 8, 2023

spine anatomy

Dignify Therapeutics Receives NIH Award for Preclinical and Clinical Development of a Novel, On-Demand, Voiding Therapy

Dignify Therapeutics LLC, a pharmaceutical and medical device development company focused on restoring bladder and bowel control for people with spinal injury, multiple sclerosis, diabetes, and the elderly, was awarded the prestigious Blueprint Neurotherapeutics Network grant from the National Institutes of Health (NIH). This 4-year award provides over $4 million in funding to support preclinical and clinical development of the Company’s lead drug candidate, DTI-117, to treat bladder and bowel dysfunction. “This new award exemplifies the foresight of, and commitment from, the NIH to develop treatments for bladder and bowel dysfunction in people suffering from these conditions” said company President and Principal Investigator, Dr. Ed Burgard. “This award will provide funds for an IND submission and a subsequent clinical trial for DTI-117”. Read more.

Source: Dignify Therapeutics website, February 27, 2023

mother post pregnancy

Decades-Long Suffering From Obstetric Injuries

Bowel leakage, the need for anal incontinence protection and a restricted social life may cause severe, decades-long suffering among women with obstetric injuries to the anal opening, according to a study from the University of Gothenburg.  The study, published in the American Journal of Obstetrics and Gynecology, comprises a total of more than 11,000 women who had given birth vaginally in Sweden, twice, in the years 1987-2000. Read more.

Source: Science Daily, February 23, 2023

man depressed

Over Half of Men Experience Some Symptoms of Urinary Incontinence, Study Finds

Over half of men in the UK have experienced some symptoms of urinary incontinence (UI) while previous studies may have underestimated the true number of men affected, the charity Prostate Cancer UK has suggested. A study found that awareness of urinary incontinence in men in the general population was lower than the prevalence of the condition would suggest. While previous research has suggested that one in 25 men over 40 will experience UI each year in the UK, Prostate Cancer UK’s survey of almost 5,000 people found that the condition could be much more common, and often affected men much earlier in their lives than had previously been believed likely. Read more.

Source: Nursing in Practice, Feburary 15, 2023

business buildings

Coloplast Launches Male Catheter Designed to Reduce the Risk of Urinary Tract Infections

The new intermittent catheter Luja™ addresses important risk factors for urinary tract infections, a significant burden for people using intermittent catheters as well as healthcare systems as a whole. Urinary tract infections represent a significant challenge for people who use intermittent catheters to empty their bladder. This includes people living with spinal cord injury, multiple sclerosis, or spina bifida. On average, intermittent catheter users have 2-3 urinary tract infections per year, which can lead to serious health complications, have a significant impact on quality of life, and result in hospitalisation, thereby putting pressure on local healthcare systems.  Read more.

Source: Yahoo News, February 2, 2023

business buildings

Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour.  Read more.

Source: BusinessWire, January 31, 2023

nerve cells

Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence

Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI).  Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.

Source: PRNewswire, January 24, 2023

exercise young woman

Incontinence Due to Pelvic Floor Issues Affects Women With DM1

Pelvic floor disorders, including urinary and anal incontinence, are common in women with myotonic dystrophy type 1 (DM1) and a cause of significant distress, according to a recent study in Canada.  “This study highlights the importance of screening these symptoms in a clinical setting and will help develop interventions to adequately treat these symptoms, taking into account the characteristics of the disease,” its researchers wrote. Ways of addressing urinary incontinence — reported by 60% of the women in this study — “should be explored due to the high prevalence of this disorder,” the team added. The study, “Prevalence of urinary incontinence and other pelvic floor disorders in women with myotonic dystrophy type 1,” was published in the journal Neuromuscular Disorders.  Read more.

Source: Bionews, January 17, 2023

business buildings

Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence

Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023.  The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.

Source: Accesswire, January 17, 2023